Senior Statistical Programmer - Remote SDTM/ADaM Lead

Emmes; Bogotá; Remote; COP 286.469.000 - 413.789.000; Vollzeit

Zusammenfassung

Emmes Group seeks a Principal Statistical Programmer to design, develop, validate, and maintain statistical programming deliverables for clinical trials and regulatory submissions. You will lead study teams, ensure CDISC standards, and guide junior programmers in a dynamic, remote environment.

Expert SAS with SDTM/ADaM fluency and strong regulatory knowledge is essential. This senior role supports cross-functional teams across regions, delivering timely, publication-ready outputs for successful

Qualifikationen

• Bachelor's or master's in CS, stats, math, life sciences, or related field.
• 7–9 years of statistical programming in pharma/biotech/CRO.
• Expert in SAS Base, SAS Macro, SAS SQL.
• Deep experience with CDISC SDTM and ADaM.
• Proven track record in clinical trial reporting and regulatory submissions.
• Strong knowledge of ICH GCP, 21 CFR Part 11, FDA/EMA expectations.
• Excellent problem-solving and attention to detail.
• Strong communication and collaboration skills.

Aufgaben

• Provide technical leadership in programming across SDTM/ADaM and study datasets.
• Develop, validate, and maintain TLFs for reports and submissions.
• Review SAPs and implement analyses accurately in code.
• Lead programmers on studies, coordinating with teams and CROs.
• Mentor junior programmers and contractors.
• Ensure compliance with CDISC, FDA, EMA standards and SOPs.
• Prepare submission-ready datasets, define.xml, and reviewer guides.
• Support ISS and ISE analyses for NDA/BLA/MAA submissions.

Kenntnisse

SAS Base

SAS Macro

SAS SQL

CDISC SDTM

CDISC ADaM

Regulatory submissions

Problem solving

Communication

Collaboration

Ausbildung

Bachelor's/Master's in Computer Science/Statistics/Life Sciences

Tools

Pinnacle 21

OpenCDISC

define.xml generators

Jobbeschreibung

Emmes Group seeks a Principal Statistical Programmer to design, develop, validate, and maintain statistical programming deliverables for clinical trials and regulatory submissions. You will lead study teams, ensure CDISC standards, and guide junior programmers in a dynamic, remote environment.

Expert SAS with SDTM/ADaM fluency and strong regulatory knowledge is essential. This senior role supports cross-functional teams across regions, delivering timely, publication-ready outputs for successful